Medical implants and fabrication of medical implants

ABSTRACT

The present invention discloses a biomechanically compatible implant, wherein arbitrary selectable discrete locations of the the implant are defined to exhibit biomechanical characteristics in accordance with biomechanical characteristics at arbitrary selectable discrete locations of a bodily tissue where the respective arbitrary selectable discrete locations of the implant are configured to be attached. The implant may be configured to repair prolapse in an embodiment. In another embodiment, the implant may be configured to repair urinary incontinence. The present invention further discloses a device for generating a biomechanical characteristics pattern of the bodily tissue and the implant. The present invention further discloses a system for designing and fabricating the biomechanically compatible implant.

BACKGROUND Field

The present invention generally relates to medical devices and moreparticularly relates to medical implants, surgical procedures ofdelivering the medical implants in a patient's body, and methods andsystems for designing and fabricating these medical implants.

Description of the Related Art

Biomechanical properties of bodily tissues such as elasticity,visco-elasticity, resistance to creep, etc may be different at differentlocations or may vary along different directions due to anisotropicnature of the bodily tissues. For example, vaginal wall propertiesdiffer along different portions and in different directions. Evenbiomechanical properties of the same wall such as anterior vaginal wallor posterior vaginal wall may be different at different locations of thesame wall. Further, biomechanical properties of anterior wall andposterior wall are different from one another. Still, same tissues ofdifferent patients such as same portions of the same vaginal wall maybehave differently biomechanically.

There is a need for a patient-specific customized implant that exhibitsbiomechanical properties and behaves biomechanically in accordance withthe biomechanical properties of the bodily tissues. There is still aneed for a device and system that is capable of designing andfabricating such a patient-specific customized implant used forreconstruction of tissues, hernia repair, prolapse repair, incontinencerepair or for any other purpose in accordance with the varyingproperties of the bodily tissues.

SUMMARY

The present invention provides a biomechanically compatible implant forproviding support to vaginal walls to treat vaginal walls prolapse in anembodiment. The biomechanically compatible implant includes a first flapconfigured to be attached to an anterior vaginal wall, wherein arbitraryselectable discrete locations of the first flap of the implant aredefined to exhibit biomechanical characteristics in accordance withbiomechanical characteristics at arbitrary selectable discrete locationsof the anterior vaginal wall where the respective arbitrary selectablediscrete locations of the first flap are configured to be attached. Thebiomechanically compatible implant further includes a second flapconfigured to be attached to a posterior vaginal wall, wherein arbitraryselectable discrete locations of the second flap of the implant aredefined to exhibit biomechanical characteristics in accordance withbiomechanical characteristics at arbitrary selectable discrete locationsof the posterior vaginal wall where the respective arbitrary selectablediscrete locations of the second flap are configured to be attached. Thebiomechanically compatible implant further includes a third flapextending from the first flap and the second flap and configured to beattached to a tissue proximate sacrum.

The present invention provides a biomechanically compatible implant forproviding support to sub-urethral or bladder neck tissues to preventleakage of urine due to incontinence in an embodiment. Thebiomechanically compatible implant includes a linear strip of mesh witha proximal portion, a medial portion and a distal portion. The medialportion is configured to be attached to sub-urethral or bladder necktissues for providing a supporting force to the sub-urethral or bladderneck tissues, wherein arbitrary selectable discrete locations of themedial portion of the linear strip of mesh are defined to exhibitbiomechanical characteristics in accordance with biomechanicalcharacteristics at arbitrary selectable discrete locations of thesub-urethral or bladder neck tissues where the respective arbitraryselectable discrete locations of the medial portion are configured to beattached. The biomechanically compatible implant includes a first sleeveremovably coupled to the proximal portion and configured be removed bypulling away a first elongate member that removably couples the firstsleeve with the proximal portion. The biomechanically compatible implantfurther includes a first dilator configured to be attached to an end ofthe proximal portion of the linear strip of mesh.

The present invention provides a device to generate a biomechanicallycompatible implant pattern for an implant that behaves in accordancewith biomechanical characteristics of a bodily tissue in an embodiment.The device includes a pressure unit for applying a defined pressure to alocation on the bodily tissue. The device further includes a sensor fordetecting a deformation caused by application of the defined pressureand a data analyzer to correlate values of the deformation and thedefined pressure so as to determine a biomechanical characteristicpattern of the bodily tissue in response to the pressure. The devicefurther includes a control unit to define an implant pattern based onthe biomechanical characteristic pattern of the bodily tissue such thatat an arbitrarily large plurality of discrete spatial coordinates,biomechanical characteristics of the implant conform with biomechanicalcharacteristics at respective spatial locations of the bodily tissuewhere the respective spatial coordinates of the implant are configuredto be positioned.

The present invention provides a system for developing a mesh-basedimplant in an embodiment. The system includes a modelling system forgenerating design models corresponding to the implant using a set ofmachine learning tools, modelling tools, and data sources acquired froma plurality of sources, wherein one of the data sources includesubject's biomechanical characteristics at arbitrarily large number oflocations of a bodily tissue where the implant is configured to beattached. The design models may be contained in a software file in anembodiment. The system further includes an additive manufacturing deviceconfigured to develop the implant by depositing layered structures,based on the design models contained in the software file that isreadable and executable by the additive manufacturing device, so that,at arbitrarily large number of locations of a so fabricated implant,biomechanical characteristics conform with the biomechanicalcharacteristics of the arbitrarily large number of locations of thebodily tissue where the arbitrarily large number of locations of theimplant are configured to be attached.

BRIEF DESCRIPTION OF THE FIGURES

The invention and the following detailed description of certainembodiments thereof may be understood with reference to the followingfigures:

FIG. 1 illustrates a schematic diagram of an implant in accordance withan embodiment of the present invention.

FIGS. 2-9 illustrate schematic diagrams of an implant for prolapserepair in accordance with different embodiments of the presentinvention.

FIG. 10 illustrates an implant for repair of urinary incontinence in anembodiment of the present invention.

FIG. 11 illustrates a medical assembly including the implant of FIG. 10,in an embodiment of the present invention.

FIG. 12 illustrates schematic diagrams of implants for prolapse repairin accordance with an embodiment of the present invention.

FIGS. 13A and 13B illustrate surgical placement of implants inaccordance with exemplary embodiments of the present invention.

FIG. 14 illustrates a method of delivering and surgically placing animplant for prolapse repair in accordance with an embodiment of thepresent invention.

FIG. 15 illustrates a method of delivering and surgically placing animplant for incontinence repair in accordance with an embodiment of thepresent invention.

FIG. 16 illustrates a device for determining biomechanicalcharacteristics of bodily tissues and generating a biomechanicalcharacteristic pattern of an implant, in accordance with an embodimentof the present invention.

FIG. 17 illustrates a system for designing and/or fabricating animplant, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

Detailed embodiments of the present invention are disclosed herein;however, it is to be understood that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition).

FIG. 1 is a schematic diagram illustrating generally, among otherthings, an example of a system and an environment in which it can beused.

The embodiments of the present invention may be implemented in slingssuitable for the treatment of male and female urinary and fecalincontinence and to effect pelvic floor, perineal floor, and pelvicprolapse repairs employing a variety of surgical approaches. Forexample, female pelvic floor repair slings such as urinary slings orpelvic prolapse repair slings may be implanted by techniques thatinvolve transvaginal, transobturator, suprapubic, pre-pubic, ortransperineal exposures or pathways, and male urinary incontinenceslings may be implanted by techniques that involve transobturator,suprapubic, or transperineal pathways. The disclosed embodiments can beused as fecal incontinence slings which may be implanted by techniquesthat involve transvaginal, transobturator, suprapubic or via perinealfloor pathways or through other methods or may be used for other upliftand reconstruction surgeries.

FIG. 1 illustrates a schematic diagram of an implant 100 in accordancewith an embodiment of the present invention. The implant 100 includes afirst flap 102, a second flap 104, and a third flap 106. The first flap102 defines a first portion 108, a second portion 110, and a mid portion112 such that a total length of the first flap is L1 and a total widthof the first flap is W1. In another embodiment, the width of the firstflap may vary across the length L1 gradually or in discrete portions.The second flap 104 defines a first portion 114, a second portion 116,and a mid portion 118 such that a total length of the second flap is L2and a total width of the second flap is W2. In another embodiment, thewidth of the second flap 104 may vary across the length L2 gradually orin discrete portions. The third flap 106 defines a first portion 120, asecond portion 122, and a mid portion 124 such that a total length ofthe third flap is L3 and a total width of the third flap is W3. Inanother embodiment, the width of the third flap 106 may vary across thelength L3 gradually or in discrete portions. The three flaps 102, 104,and 106 can be defined rectangular or triangular or trapezoidal orcurved in shape or may have any other shape. In an example, the threelengths L1, L2, and L3 may be equal or different. Similarly, the widthsW1, W2, and, W3 may be equal or different.

In various embodiments, the implant 100 can be used for the treatment ofa pelvic floor disorder. In some embodiments, the implant 100 can beused to suspend various bodily locations in a body of a patient such aspelvic organ of a patient's body such as for the treatment of pelvicorgan prolapse. In some embodiments, the implant 100 can be used in aurinary sling with some modifications as will be discussed later. Insome embodiments, the implant 100 can be used in a retropubicincontinence sling. In some embodiments, the implant 100 can beconfigured to be delivered by way of a transvaginal approach or atransobturator approach or vaginal pre-pubic approach or a laparoscopicapproach or can be delivered through other methods and may be positionedat various locations within a patient's body without limitations. Insome embodiments, the implant 100 can be delivered through asacrocolpopexy procedure.

The first flap 102 may be configured to be attached to a first bodilyportion. In an embodiment, the first bodily portion may be an anteriorvaginal wall such that the first flap 102 may be configured to bepositioned at the anterior vaginal wall. The second flap 104 may beconfigured to be attached to a second bodily portion. In an embodiment,the second bodily portion may be a posterior vaginal wall such that thesecond flap 104 may be configured to be positioned at the posteriorvaginal wall. The third flap 106 may be configured to be attached to athird bodily portion. In an embodiment, the third bodily portion may besacrum or tissues proximate the sacrum or lumbar vertebra, tail bone, orillium portion of hip bone or uterus, or any other location or nearbytissues such that the third flap 106 may be configured to be positionedat or proximate to the sacrum or lumbar vertebra, tail bone, and illiumportion of hip bone or uterus or any other location or nearby tissues.

The first bodily portion may exhibit a definite biomechanical behaviorin a defined set of physical conditions. For example, the first bodilyportion may behave different than the second bodily portion. Even, twodifferent locations at the first bodily portion may behave differently.For example two different locations at the anterior vaginal wall maybehave differently. Similarly, two different locations at the secondbodily portion may behave differently. For example, two differentlocations at the posterior vaginal wall may behave differently. In anexample, five different locations at the anterior vaginal wall maybehave differently and five different locations at the posterior vaginalwall may behave differently. In an example, arbitrary selectabledifferent locations at the anterior vaginal wall may behave differentlyand arbitrary selectable different locations at the posterior vaginalwall may behave differently. In an example, arbitrary selectable largenumber of different locations at the anterior vaginal wall may behavedifferently and arbitrary selectable large number of different locationsat the posterior vaginal wall may behave differently.

In an example, biomechanical behaviour of an anterior vaginal wall for afirst patient may be different from biomechanical behaviour of ananterior vaginal wall of a second patient as same tissues or organs ofdifferent patients may behave differently and may exhibit varyingbiomechanical characteristics. This may be due to age, unique individualtissue characteristics, intra-abdominal force interactions orintra-abdominal pressures, pregnancy or childbirth for example pregnancyor childbirth may alter biomechanical characteristics of tissues ofvaginal walls, obesity, body mass index (BMI), specific tissuecharacteristics, specific vaginal wall such as anterior vaginal wall orposterior vaginal wall may have different biomechanical characteristics,position or location of a tissue with respect to other tissues such asdistance from abdomen or distance from uterus of a specific location ofan anterior vaginal wall or a posterior vaginal wall, transmission ofabdominal pressures to specific locations, anatomy of tissues at aspecific location, orientation of tissues at a specific location withother tissues, composition of tissues at different locations such ascollagen levels at different locations or in different tissues or ofdifferent persons, state and intensity of prolapse, types of prolapse,associated diseases to a subject, vaginal delivery, chronic increasedintra-abdominal pressure caused by obesity, chronic respiratory diseaseand/or related cough, chronic constipation, repetitive occupationalactivities, heavy lifting, hormones, pelvic organ cancers and the like.

In an example, ligaments and the vaginal walls of young women mayexhibit biomechanical behaviour different than those of older women.Furthermore, young women's tissues may differ slightly from olderwomen's tissues. Aging and possibly diverse trauma may have an impact onthe mechanical behaviour of pelvic floor tissues. Over time pelvic floorligaments and vaginal tissues may differentiate and acquire differentmechanical behaviour. In an example, biomechanical characteristics ofvaginal tissues or vaginal walls between women with and without pelvicorgan prolapse (POP) may vary. In an example, the occurrence of POP mayraise values of stiffness (E) and maximum stress in the anterior vaginalwall. Women with severe anterior vaginal prolapse may present higherlevels of stiffness and maximum stress compared to those with lower POPstages. In an example, women with POP may present significant changes ofbiomechanical properties in the vagina. In an example, virgin tissuesmay be more elastic and strong. Pregnancy may have a great impact ontissue composition and biomechanical properties. Biochemical changes intissue protein composition may in an example cause altered biomechanicalproperties. In an example, vaginal tissues may show significantly highertotal collagen and glycosaminoglycan values nearest the cervix. In anexample, a proximal region of vaginal wall may be the stiffest (Young'smodulus, p<0.05), strongest (maximum stress, p<0.05) compared to distalregion, and may be the most elastic (such as permanent strain) accordingto one study. In an example, the form, size, and situation of the uterusmay vary at different periods of lifetime and under differentcircumstances which may cause changes in interactions of the forces andalter biomechanical characteristics at other tissues or organs at thesame time changing biomechanical characteristics of uterus itself. In anexample, more obese women may have stiffer tissue properties.

In an example, the first flap 102 (that may be configured to be attachedto the anterior vaginal wall) may be defined such that at least twodifferent locations of the first flap 102 exhibit biomechanicalcharacteristics in accordance with the biomechanical characteristics ofat least two different locations of the anterior vaginal wall where therespective two different locations of the first flap 102 are configuredto be attached. In an example, the first flap 102 may be defined suchthat at least five different locations of the first flap 102 exhibitbiomechanical characteristics in accordance with the biomechanicalcharacteristics of five different locations of the anterior vaginal wallwhere the respective five different locations of the first flap 102 areconfigured to be attached. In another example, the first flap 102 may bedefined such that arbitrary selectable different locations of the firstflap 102 exhibit biomechanical characteristics in accordance with thebiomechanical characteristics at the arbitrary selectable differentlocations of the anterior vaginal wall where the respective arbitraryselectable different locations of the first flap 102 are configured tobe attached. In an example, the first flap 102 may be defined such thatarbitrary selectable large number of different locations of the firstflap 102 exhibit biomechanical characteristics in accordance with thebiomechanical characteristics at the arbitrary selectable large numberof different locations of the anterior vaginal wall where the respectivearbitrary selectable large number of different locations of the firstflap 102 are configured to be attached. In this way, the first flap 102may be configured to define the biomechanical characteristics atdifferent locations so as to emulate the biomechanical behavior of thefirst bodily portion such as the anterior vaginal wall at differentarbitrary selectable locations. The biomechanical characteristics of thefirst flap 102 and the first bodily portion can be identified through aset of numerical values that may signify a degree or measure of thebiomechanical characteristics of a particular type. For example, thebiomechanical characteristics can represent elasticity and acorresponding numerical value can define modulus of elasticity or adegree of elasticity of the first flap at a particular location or ofthe anterior vaginal wall at a particular location. In some embodiments,the biomechanical characteristics can represent stiffness. In someembodiments, the biomechanical characteristics can represent strength.In some embodiments, the biomechanical characteristics can representresistance to creep. In some embodiments, the biomechanicalcharacteristics can represent hyperelasticity. In some embodiments, thebiomechanical characteristics can represent viscohyperelasticity. Insome embodiments, the biomechanical characteristics can representanisotrophicity. In some embodiments, the biomechanical characteristicscan represent maximum stress, hysteresis, extensibility (the capacity tobe stretched), plasticity (the property to get permanently changed by adeforming force), and torsion (the capacity to be deformed when exposedto a torsional force), stiffness index, stretch ratio, and the like. Invarious embodiments, the first flap 102 may be configured so that one ormore of elasticity, hyperelasticity, resistance to creep, stiffness,strength, maximum stress, hysteresis, extensibility, plasticity, andtorsion, stiffness index, stretch ratio, and other such characteristics(without limitations) of the first flap 102 is in accordance withelasticity, hyperelasticity, resistance to creep, stiffness, strength,maximum stress, hysteresis, extensibility (the capacity of skin to bestretched), plasticity (the property of skin when it is permanentlychanged by a deforming force), and torsion (the capacity of skin to bedeformed when exposed to a torsional force), stiffness index, stretchratio, and the like properties of the anterior vaginal wall at thearbitrary selectable different locations.

In an example, the second flap 104 (that may be configured to beattached to the posterior vaginal wall) may be defined such that atleast two different locations of the second flap 104 exhibitbiomechanical characteristics in accordance with the biomechanicalcharacteristics of at least two different locations of the posteriorvaginal wall where the respective two different locations of the secondflap 104 are configured to be attached. In an example, the second flap104 may be defined such that at least five different locations of thesecond flap 104 exhibit biomechanical characteristics in accordance withthe biomechanical characteristics of five different locations of theposterior vaginal wall where the respective five different locations ofthe second flap 104 are configured to be attached. In an example, thesecond flap 104 may be defined such that arbitrary selectable differentlocations of the second flap 104 exhibits biomechanical characteristicsin accordance with the biomechanical characteristics at the arbitraryselectable different locations of the posterior vaginal wall where therespective arbitrary selectable different locations of the second flap104 are configured to be attached. In an example, the second flap 104may be defined such that arbitrary selectable large number of differentlocations of the second flap 104 exhibits biomechanical characteristicsin accordance with the biomechanical characteristics at the arbitraryselectable large number of different locations of the posterior vaginalwall where the respective arbitrary selectable large number of differentlocations of the second flap 104 are configured to be attached. In thisway, the second flap 104 may be configured to define the biomechanicalcharacteristics at different locations so as to emulate thebiomechanical behaviour of the second bodily portion such as theposterior vaginal wall at different locations. The biomechanicalcharacteristics of the second flap 104 and the second bodily portion canbe identified through a set of numerical values that may signify adegree or measure of the biomechanical characteristics of a particulartype such as those discussed above with respect to the first flap 102.

In an example, the third flap 106 (that may be configured to be attachedto the third bodily portion) may be defined such that at least twodifferent locations of the third flap 106 exhibit biomechanicalcharacteristics in accordance with the biomechanical characteristics ofat least two different locations of the third bodily portion where therespective at least two different locations of the third flap 106 areconfigured to be attached. In an example, the third flap 106 may bedefined such that five different locations of the third flap 106exhibits biomechanical characteristics in accordance with thebiomechanical characteristics of five different locations of the thirdbodily portion where the respective five different locations of thethird flap 106 are configured to be attached. In an example, the thirdflap 106 may be defined such that arbitrary selectable differentlocations of the third flap exhibit biomechanical characteristics inaccordance with the biomechanical characteristics at the arbitraryselectable different locations of the third bodily portion where therespective arbitrary selectable different locations of the third flap106 are configured to be attached. In an example, the third flap 106 maybe defined such that arbitrary selectable large number of differentlocations of the third flap 106 exhibit biomechanical characteristics inaccordance with the biomechanical characteristics at the arbitraryselectable large number of different locations of the third bodilyportion where the respective arbitrary selectable large number ofdifferent locations of the third flap 106 are configured to be attached.In this way, the third flap 106 may be configured to define thebiomechanical characteristics at different locations so as to emulatethe biomechanical behaviour of the third bodily portion. Thebiomechanical characteristics of the third flap 106 and the third bodilyportion can be identified through a set of numerical values that maysignify a degree or measure of the biomechanical characteristics of aparticular type such as those discussed above.

In various embodiments, the biomechanical characteristics of the firstflap 102 or the second flap 104 or the third flap 106 can be defined orvaried for example by defining or varying one or more of shape, size,fabrication method, structure, profile, knit structure, pore size,material of fabrication, fiber orientation, knit pattern, weave pattern,pore construct, knit structure, knitting pattern, weaving pattern, meshstrands, fibres with holes or without holes, number of such holes infibres per unit length or number of cells per unit length longitudinallyor in a transverse direction or in any other direction and the like. Insome embodiments, for example, the biomechanical characteristics of thefirst flap 102 or the second flap 104 or the third flap 106 can bevaried by varying shape. For example, the first flap 102 which may beconfigured to be attached to the anterior vaginal wall may be defined bypores with a square, rectangular, triangular or any other shape or acombination of these shapes, at different locations of the first flap102 so as the first flap 102 to closely behave in accordance with thebiomechanical behaviour of the anterior vaginal wall at differentlocations. In some embodiments, a specific type of material may be usedto fabricate a particular portion of the first flap 102 or the secondflap 104 or the third flap 106 so as to provide a desired biomechanicalcharacteristic. For example, a viscoelastic medical grade polymer withnecessary viscoelasticity can be used for fabricating a specific portionto provide a desired viscoelastic characteristic. In embodiments,several different portions (such as 2, 3, 4, 5, 6, 7, 8, 9, 10 or evenmore arbitrary selectable locations) of the first flap 102 may beprovided with different shape, size, fabrication method, structure,profile, knit structure, pore size, material of fabrication, fibreorientation, knit pattern, weave pattern, pore construct, knitstructure, knitting pattern, weaving pattern, mesh strands, fibres withholes or without holes, number of such holes in fibres per unit lengthor number of cells per unit length longitudinally or in a transversedirection or in any other direction or a combination of these, and thelike. Similarly, in embodiments, several different portions (such as 2,3, 4, 5, 6, 7, 8, 9, 10 or even more or arbitrary selectable portions)of the second flap 104 may be provided with different shape, size,fabrication method, structure, profile, knit structure, pore size,material of fabrication, fibre orientation, knit pattern, weave pattern,pore construct, knit structure, knitting pattern, weaving pattern, or acombination of these, and the like. Therefore, the same flap such as thefirst flap 102 or the second flap 104 or the third flap 106 may includeeven more than one type of pore constructs, shape, size, fabricationmethod, structure, profile, knit structure, pore size, material offabrication, fibre orientation, knit pattern, weave pattern, poreconstruct, knit structure, knitting pattern, weaving pattern, meshstrands, fibres with holes or without holes, number of such holes infibres per unit length or number of cells per unit length longitudinallyor in a transverse direction or in any other direction or may eveninclude a combination of these ways without limitations for achievingdesired biomechanical characteristics. In an example, in case of amesh-based implant, several different portions of the same flap may bewoven or knit with different tensioning force so as to achieve a desiredbiomechanical characteristic at a particular location of the first flap102 or the second flap 104 or the third flap 106. In accordance withvarious embodiments, various other ways of obtaining desiredbiomechanical characteristics may be employed without limitations. Inaccordance with embodiments, a particular way of providing desiredbiomechanical characteristics may be used either alone or in combinationwith other ways. The implant 100 may be a mesh-based structure or aplanar structure without any mesh structure. Accordingly, select ways ofachieving a desired biomechanical characteristic may be used based onwhether the mesh-based implant is used or the non-mesh based implant isused.

The anterior vaginal wall and the posterior vaginal wall may exhibitdifferent biomechanical properties along different directions even atthe same location due to anisotropic nature. In some embodiments, thefirst flap 102 and the second flap 104 may therefore be configured tobehave differently along different directions such as in a longitudinaldirection or in a transverse direction or in any other direction.Various ways of maintaining and achieving desired biomechanicalcharacteristics as discussed above may be employed and combined in amanner so as to get a desired biomechanically compatible implant thatbehaves in accordance with the behaviour of the anterior vaginal walland the posterior vaginal wall at different locations and in differentdirections.

In an embodiment, the implant 100 can be configured as a Y-shapedmesh-based implant 200 as shown in FIG. 2. FIG. 2 illustrates aschematic view of the mesh-based implant 200 (interchangeably referredto as implant 200 merely for simplicity of description) in accordancewith an embodiment of the present invention. As shown, the implant 200includes a first flap 202 similar to the first flap 102, a second flap204 similar to the second flap 104, and a third flap 206 similar to thethird flap 106. In accordance with the illustrated embodiments of FIG.2, the first flap 202, the second flap 204 and the third flap 206 aremade of a mesh structure. The mesh structure can be fabricated from anatural material or a synthetic material.

In some embodiments, the implant 200 is made of a synthetic materialsuch as a polymeric material and the like. In some embodiments, theimplant 200 includes a polymeric mesh body. The mesh body may comprise achain link fence-like design. In such designs, the fibers or strands ofthe mesh may be woven, linked, or otherwise connected, and may share thestress of a supported load. In other embodiments, the implant 200 mayinclude a polymeric planar body without mesh cells and structures.Exemplary polymeric materials are polypropylene, polyester,polyethylene, nylon, PVC, polystyrene, and the like. In someembodiments, the implant 200 is made of a non-woven polymeric material.In some other embodiments, the implant 200 can be made of naturalmaterials such as biologic material or a cadaveric tissue and the like.Additionally, in some embodiments, the implant 200 is stretchable andflexible to adapt movements along the anatomy of the human body. In someembodiments, the attributes such as softness, lightness, conformity andstrength may be required in the implant 200 for efficient tissue repairand implantation. In some embodiments, the implant 200 can be made ofbiodegradable materials. In some embodiments, the implant 200 can bemade of non-biodegradable material. In some embodiments, the implant 200can be made of medical grade materials.

In an example, the first flap 202, the second flap 204, and the thirdflap 206 can be configured to be attached to the first bodily portion,the second bodily portion, and the third bodily portion as discussed inconjunction with FIG. 1. In the illustrated mesh-based implant 200, thefirst flap 202 is defined by first biomechanical characteristics atlocation (or region or portion or location referred interchangeablythroughout the document) 1, second biomechanical characteristics atlocation 2, third biomechanical characteristics at location 3, fourthbiomechanical characteristics at location 4, and fifth biomechanicalcharacteristics at location 5 such that the five different locations ofthe first flap 202 will behave differently when attached to the anteriorwall where the first flap 202 is configured to be attached to. Thedifferent biomechanical behaviour of the first flap 202 at fivedifferent locations is in accordance with different biomechanicalbehaviour of the anterior vaginal wall at five different locations wherethe five different locations of the first flap 202 are configured to beattached to. In an embodiment, a location at a bodily portion or a flapas discussed in the document may represent specific spatial coordinateor a region bounded within a plurality of spatial coordinates. In anembodiment, a location of the mesh-based flap such as 202 may representone pore such that different locations reflect different regions coveredby different pores of the flap 202. As shown in FIG. 2, the differentbiomechanical characteristics at the five depicted locations 1, 2, 3, 4,and 5 are obtained by varying pore sizes in the five depicted locations,in an embodiment. It must be appreciated, that the varying biomechanicalcharacteristics can be defined based on requirements using other ways ora combination of ways such as those discussed earlier in conjunctionwith FIG. 1.

In accordance with an embodiment, FIG. 3 illustrates the implant 200with the five different locations location 1, location 2, location 3,location 4, and location 5 (referred interchangeably as five differentlocations or five locations or five regions or five portions) havingvarying biomechanical characteristics obtained by a combination ofvarying pore sizes, pore shapes, and orientations of fibres. The poresizes in any two or more of the locations may be equal or different invarious embodiments in order to define the required biomechanicalcharacteristics. In an embodiment, the first flap 202 may include ashift region such as a shift region 208 between two portions withdifferent biomechanical characteristics. The shift region 208 may bemesh-based or non-mesh based such as a planar structure. The shiftregion 208 may include a different type of knit pattern in anembodiment. In an example, the shift region such as 208 may merelyinclude a few sutures or fibres that may join the different locationssuch as location 1 and location 2. In an example, there may not be anyshift region similar to 208 and the different regions with differentbiomechanical properties may simply couple directly with one another.

In accordance with an embodiment, FIG. 4 illustrates another embodimentof the implant 200 with five different types of knit structures at thefive different locations 1, 2, 3, 4, and 5 (1-5) of the first flap 202so as to define different types of biomechanical characteristics at thefive different locations 1-5 of the first flap 202. As depicted in FIGS.4A, 4B, 4C, 4D, and 4E, the five different knit patterns can be obtainedby knitting material fibres in different ways with specificallycontrolled knit parameters such as to result in defined biomechanicalcharacteristics in the different locations 1-5.

FIG. 5 illustrates another example of the implant 200 with fivedifferent types of coatings applied to the five different locations ofthe first flap 202 or made of five different materials having differentbiomechanical properties for example. In a similar manner, the firstflap 202 can be defined and configured to behave in accordance withbehaviour of the anterior vaginal wall using other ways or a combinationof those ways. In an example, area covered by each location of the firstflap can be reduced so as to customize and vary the biomechanicalcharacteristics across smaller regions thereby more accurately emulatingbehaviour of the anterior vaginal wall. For example, using computerizedand intelligent modelling and fabrication techniques as discussed later,the area of each region or location or portion can be reduced to porelevels or reduced even further or to micro levels such that the firstflap 202 may be distributed to hundreds of locations or portions orregions or arbitrary selectable locations or portions or regions witheach location or region having different biomechanical characteristicsthan the other at least to some extent in one or the other way ofcharacteristics and in one or the other direction. The FIGS. 2-5illustrate configuration of the first flap 202 as an example. Similarly,the second flap 204 can be configured for variations in thebiomechanical properties across different regions or locations so as thesecond flap 204 to behave in accordance with the posterior vaginal wallsuch as shown in FIG. 6 with both the first flap 202 and the second flap204 with varying knit structures across five different regions.Similarly, the third flap 206 can be configured for variations in thebiomechanical properties across different regions or locations so as thethird flap 206 to behave in accordance with the third bodily portion. Insome embodiments, the third flap 206 may not include differentconfigurations at different locations and the entire third flap 206 maybe fabricated and defined to include a single pattern or material orstructure etc. In an example, a location of the first flap 202 or thesecond flap 204 or the third flap 206 with defined and samebiomechanical characteristics can extend over an entire length or widthof the first flap 202 or the second flap 204 or the third flap 206. Inan example, a location of the first flap 202 or the second flap 204 orthe third flap 206 with defined and same biomechanical characteristics(also referred to as locations or regions of same biomechanicalcharacteristics) may not extend over an entire width or length of thefirst flap 202 or the second flap 204 or the third flap 206 as shown inFIG. 7 with respect to the first flap 202 where one or more of thelocations of same biomechanical characteristics of the first flap 202may extend over a portion of the width. In a similar manner, thelocations may or may not extend over a portion of the length such asshown in FIG. 8.

In accordance with an embodiment, the implant 200 may be configured fordifferent shapes at different arbitrary locations. As shown in FIG. 9,the shapes of the implant 200 at three different locations A, B, and Cor regions vary such that at a first location A, the shape is curved, ata second locations B, the shape is rectangular, and at a third locationC, the shape is trapezoidal. Similarly, the shapes can be varied atarbitrary selectable different locations in embodiments. The varyingshapes may be defined based on anatomical structure at a particularlocation of bodily tissues and based on biomechanical characteristicsdesired at a particular location.

The various embodiments discussed above in conjunction with FIGS. 1-9with respect to the first flap 202 or the second flap 204 may be definedwith respect to the first flap 202 or the second flap 204 or the thirdflap 206 without limitations in various embodiments.

The implant 100 or 200 illustrated in conjunction with FIGS. 1-9 may beconfigured such that one or two flaps of the three flaps 202, 204, and206 of the Y-shape implant 100 or 200 can be fabricated as aconventional mesh or non-mesh strip such that the biomechanicalcharacteristics of the one or two flaps may not vary substantially atdifferent arbitrary selectable locations or regions or at two or morethan two locations or regions of the respective one or two flaps. In anembodiment, the Y-shaped implant 200 can be fabricated as a single piecewith the three flaps 202 or 204 or 206 such that the three flaps 202 or204 or 206 extend from one another. In another embodiment, the threeflaps 202 or 204 or 206 of the implant 200 may be fabricated separatelyand then can be coupled together before placement such as by a physicianor a surgeon etc. In other embodiments, the implant 200 can beconfigured to define another shape such as a rectangular, square,trapezoidal, curved, or any other shape.

FIG. 10 illustrates an example of an implant 1000 defined as a linearstrip of mesh and configured to support urethra or bladder neck orproximate tissues for preventing leakage of urine due to incontinence.The implant 1000 may include an elongate body member 1002 with a firstportion 1004, a second portion 1006, and a medial portion 1008.

The first portion 1004 may be configured to be attached to a firstbodily portion. The second portion 1006 may be configured to be attachedto a second bodily portion. The medial portion 1008 may be configured tobe attached to a third bodily portion. In an embodiment, the thirdbodily portion may be suburethral tissues, urethra, bladder neck, ornearby tissues such that the medial portion 1008 may be configured to bepositioned at or proximate to the suburethral tissues, urethra, bladderneck, or nearby tissues or any other location or nearby tissues thereof.

The third bodily portion may exhibit a definite biomechanical behaviourin a defined set of physical conditions. For example, the third bodilyportion may behave differently than the second bodily portion and thefirst bodily portion. Even, two different locations at the third bodilyportion may behave differently. For example two different locations orregions at tissues underneath the urethra or bladder neck may behavedifferently. Similarly, two different locations at the second bodilyportion or the first bodily portion may behave differently. In anexample, five different locations at the third bodily portion may behavedifferently. In an example, arbitrary selectable different locations atthe third bodily portion may behave differently. In an example,arbitrary selectable large number of different locations at the thirdbodily portion may behave differently.

In an example, biomechanical behaviour of the third bodily portion for afirst patient may be different from biomechanical behaviour of the thirdbodily portion of a second patient as same tissues or organs ofdifferent patients may behave differently and may exhibit varyingbiomechanical characteristics. This may be due to age, unique individualtissue characteristics, intra-abdominal force interactions orintra-abdominal pressures or other factors mentioned elsewhere in thedocument.

In an example, the medial portion 1008 may be defined such that at leasttwo different locations of the medial portion 1008 exhibit biomechanicalcharacteristics in accordance with biomechanical characteristics of atleast two different locations of the third bodily portion where therespective two different locations of the medial portion 1008 areconfigured to be attached. In an example, the medial portion 1008 may bedefined such that at least five different locations of the medialportion 1008 exhibit biomechanical characteristics in accordance withthe biomechanical characteristics of five different locations of thethird bodily portion where the respective five different locations ofthe medial portion 1008 are configured to be attached. In an example,the medial portion 1008 may be defined such that arbitrary selectabledifferent locations of the medial portion 1008 exhibit biomechanicalcharacteristics in accordance with biomechanical characteristics ofarbitrary selectable different locations of the third bodily portionwhere the respective arbitrary selectable different locations of themedial portion 1008 are configured to be attached. In an example, themedial portion 1008 may be defined such that arbitrary selectable largenumber of different locations of the medial portion 1008 exhibitbiomechanical characteristics in accordance with biomechanicalcharacteristics of arbitrary selectable large number of differentlocations of the third bodily portion where the respective arbitraryselectable different locations of the medial portion 1008 are configuredto be attached. In this way, the medial portion 1008 may be configuredto define the biomechanical characteristics at different locations so asto emulate the biomechanical behaviour of the third bodily portion suchas sub urethral tissues or urethra or bladder neck or other proximatetissues at different locations. The biomechanical characteristics of themedial portion 1008 can be identified through a set of numerical valuesas discussed earlier above in conjunction with various figures. Thevarious biomechanical characteristics discussed above in conjunctionwith other embodiments can be considered for the implant 1000. In asimilar manner, optionally, the first portion 1004 and the secondportion 1006 may also be configured to behave in accordance with thefirst bodily portion and the second bodily portion respectively.

In various embodiments, the large number of arbitrary selectabledifferent locations may be defined and biomechanical characteristicsthereon may be determined using computer-based and automated systemssuch that the large number may be hundreds of locations or even moresuch that the computer-based or automated system may create a pattern orbiomechanical characteristics gradient across a bodily tissue or aportion of the bodily tissue.

In various embodiments, the biomechanical characteristics of the firstportion 1004, the second portion 1006, and the medial portion 1008 canbe defined or varied for example by defining or varying one or more ofshape, size, fabrication method, structure, profile, knit structure,pore size, material of fabrication, fibre orientation, knit pattern,weave pattern, pore construct, knit structure, mesh strands/fibres withholes or without holes or number of such holes in fibres per unit lengthor number of cells per unit length longitudinally or in a transversedirection or in any other direction or may even include a combination ofthese ways for obtaining desired biomechanical characteristics and thelike as discussed above in conjunction with other embodiments.

FIG. 11 illustrates a medical assembly in an embodiment. The medicalassembly 1100 includes the implant such as 1000, a first sleeve 1102, asecond sleeve 1104, a tab 1106, a first elongate member 1108, and asecond elongate member 1110. The first sleeve 1102 and the second sleeve1104 are configured to shield the first portion 1004 and the secondportion 1006 of the implant 1000. In some embodiments, the first sleeve1102 and the second sleeve 1104 can be thin wall flat tubes. In someembodiments, the first sleeve 1102 and the second sleeve 1104 are madeof polymer and may be colored for easy visualization. In otherembodiments, the first sleeve 1102 and the second sleeve 1104 can bemanufactured from an opaque or a transparent plastic film. Thetransparent plastic film enables visual examination of the implant 1000.In an example, length of the first sleeve 1102 is sufficient to envelopor shield the first portion 1004 of the implant 1000 and length of thesecond sleeve 1104 is sufficient to shield the second portion 1006 ofthe implant 1000. In various embodiments, the first portion 1004 is afirst end portion of the implant 1000 and the second portion 1006 is asecond end portion of the implant 1000 such that the first sleeve 1102and the second sleeve 1104 are configured to enclose the first endportion and the second end portion respectively of the implant 1000. Incertain embodiments of the present invention, the first and the secondsleeves 1102 and 1104 shield only the first portion 1004 and the secondportion 1006 of the implant 1000 such that the mid portion 1008 of theimplant 1000 remains un-shielded. The un-shielded mid portion 1008 isconfigured to interact with a bodily tissue upon placement. The lengthof the implant 1000 that is shielded with the sleeves 1102 and 1104 canvary based on requirements.

The medical assembly 1100 may also include a first dilator 1112configured to be coupled to the first sleeve 1102, and a second dilator1114 configured to be coupled to the second sleeve 1104. The firstdilator 1112 and the second dilator 1114 are configured to be coupledrespectively to distal ends 1116 and 1118 of the first sleeve 1102 andthe second sleeve 1104. The first dilator 1112 and the second dilator1114 may be heat bonded respectively to the first sleeve 1102 and thesecond sleeve 1104. In some embodiments, the first dilator 1112 and thesecond dilator 1114 may be further configured to be coupled to adelivery device (not shown). The delivery device can be a medicalinstrument that can be used to facilitate delivery of the medicalassembly 1100 including the implant 1000 within the patient's body. Insome embodiments, the first dilator 1106 and the second dilator 1108 canbe small in diameter for a less invasive surgery.

The medical assembly 1100 may further include the tab 1106 configured tobe coupled to the implant 1000. The tab 1106 is configured to identifythe medial portion 1008 of the implant 1000 and provide for equal lengthof the implant 1000 on either side of a body tissue or organ required tobe balanced such as a urethra of the patient. In some embodiments, thetab 1106 can be colored for easy visualization during a surgicalprocedure.

In certain embodiments, the first elongate member 1108 is configured toremovably couple the implant 1000 with the first sleeve 1102 and thesecond elongate member 1110 is configured to removably couple theimplant 1000 with the second sleeve 1104. The first elongate member 1108and the second elongate member 1110 include one of a thread, a medicalsuture, a filament, a rope, and the like. The first sleeve 1102 and thesecond sleeve 1104 may be configured to be removably coupled to theimplant 1000 with a single elongate member in other embodiments. Thesleeves 1102 and 1104 may be removed from the implant 1000 by pullingthe elongate members 1108 and 1110 thereby removing the sleeves 1102 and1104 from the body after positioning and placement of the implant 1000in the body at the target site. The sleeves 1102 and 1104 may preventthe implant 1000 from contaminations and thus may prevent the body frominfection.

In embodiments, the implant 1000 may include or be coupled to anchors,or tangs or other structures for facilitating positioning and fixationof the implant 1000 with bodily tissues. In some embodiments, theimplant 1000 may be fixed to tissues using glue, staples, stitches andthe like.

In accordance with various embodiments discussed in conjunction withFIGS. 1-11, the first flap such as 202 or the second flap such as 204 orthe third flap such as 206 or the elongate body member 1002 may bedefined such as to provide biomechanical characteristics at distinctlocations in accordance with biomechanical characteristics of bodilytissues where the respective distinct locations of the first flap 202 orthe second flap 204 or the third flap 206 or the elongate body member1002 may be configured to be attached in association with specificattributes of an individual subject. For example, the first flap 202 ofthe implant 200 may be configured such that the biomechanicalcharacteristics of the first flap 202 at five distinct locations such as1-5 may be defined in accordance with the biomechanical characteristicsof respective five different locations where these locations of thefirst flap 202 are configured to be attached in association withspecific attributes of the individual subject for which the implant 200is designed and used. The specific attributes of an individual subjectmay refer to such as age, unique individual tissue characteristic, andthe like without limitations that may result in variations inbiomechanical characteristics of even same locations of same tissuesbetween two or more individual subjects. For example, FIG. 12illustrates two different implants 200A and 200B, wherein 200A isconfigured to be attached to a first patient and 200B is configured tobe associated with a second patient. A first location or region orportion of a first flap 202A of the implant 200A is configured to beattached to a first portion of an anterior vaginal wall of a firstsubject, a second portion of the first flap 202A of the implant 200A isconfigured to be attached to second portion of the anterior vaginal wallof the first subject, a third portion of the first flap 202A of theimplant 200A is configured to be attached to a third portion of theanterior vaginal wall of the first subject, a fourth portion of thefirst flap 202A of the implant 200A is configured to be attached to afourth portion of the anterior vaginal wall of the first subject, and afifth portion of the first flap 202A of the implant 200A is configuredto be attached to a fifth portion of the anterior vaginal wall of thefirst subject. Similarly, a first portion of a first flap 202B of theimplant 200B is configured to be attached to a first portion of ananterior vaginal wall of the second subject, a second portion of thefirst flap 202B of the implant 200B is configured to be attached to asecond portion of the anterior vaginal wall of the second subject, athird portion of the first flap 202B of the implant 200B is configuredto be attached to third portion of the anterior vaginal wall of thesecond subject, and a fourth portion of the first flap 202B of theimplant 200B is configured to be attached to a fourth portion of theanterior vaginal wall of the second subject, and a fifth portion of thefirst flap 202B of the implant 200B is configured to be attached to afifth portion of the anterior vaginal wall of the second subject. In anexample, the first portion of the first implant 200A and the firstportion of the second implant 200B may be configured to be attached toalmost similar locations of anterior vaginal walls of the two differentsubjects. Similarly, the second portion of the first implant 200A andthe second portion of the second implant 200B may be configured to beattached to almost similar positions of the anterior vaginal walls ofthe two different subjects, the third portion of the first implant 200Aand the third portion of the second implant 200B may be configured to beattached to almost similar positions of the anterior vaginal walls ofthe two different subjects, the fourth portion of the first implant 200Aand the fourth portion of the second implant 200B may be configured tobe attached to almost similar positions of the anterior vaginal walls ofthe two different subjects, and the fifth portion of the first implant200A and the fifth portion of the second implant 200B may be configuredto be attached to almost similar positions of the anterior vaginal wallsof the two different subjects. The biomechanical characteristics of thesame portions of the vaginal walls of the two different subjects mayhowever vary due to specific individual subject attributes as discussedabove. The biomechanical characteristics of the first flap 202A of thefirst implant 200A and the biomechanical characteristics of the firstflap 202B of the second implant 200B may therefore be defineddifferently in accordance with the biomechanical characteristics of thetwo different patients using one or more of ways of obtaining desiredbiomechanical characteristics such as discussed earlier in conjunctionwith various figures so as to consider variations due to individualsubject attributes. For example, FIG. 12 shows that knit pattern or poresizes or orientation or fabrication material of the first location ofthe first flap 202A of the first implant 200A is different than knitpattern or pore sizes or orientation or fabrication material of thefirst location of the first flap 202B of the second implant 200B.Similarly, patterns of other regions or locations of the two implants200A and 200B may be configured differently so as to define requiredbiomechanical characteristics. In accordance with an exemplaryembodiment, FIG. 12 is discussed with respect to variations inbiomechanical characteristics of the first flap 202A of the firstimplant 200A and the first flap 202B of the second implant 200B.Similarly, a second flap 204B of the first implant 200A and a secondflap 204B of the second implant 200B; and a third flap 206A of the firstimplant 200A and a third flap 206B of the second implant 200B may alsobe configured differently for the two different subjects or even moresubjects in accordance with individual subject attributes.

In an aspect, the individual specific attributes may be representedthrough a set of numerical values that may be determined specificallyfor each subject. In an aspect, the individual specific attributes maybe considered by employing a normalization factor for each attributeduring configuring and design of an implant such as the implant 100, 200or 200A or 200B discussed in conjunction with various figures above.

Therefore, the first flap 202A of the first implant 200A may include aplurality of locations or regions such that biomechanicalcharacteristics at each of the locations or along each of the regionsare defined in accordance with respective arbitrary selectable locationsat the anterior vaginal wall where the plurality of locations or regionsof the first flap are configured to be attached to. The biomechanicalcharacteristics at the plurality of locations or along the plurality ofregions may be defined by using one of the several ways as discussedabove. The biomechanical characteristics of the arbitrary selectablelocations can be dependent on spatial coordinates along the anteriorvaginal wall and specific individual subject attributes. Similarly, thesecond flap 204A of the first implant 200A may include a plurality oflocations or regions such that biomechanical characteristics at each ofthe plurality of locations or along each of the plurality regions aredefined in accordance with respective arbitrary selectable locations atthe posterior vaginal wall where the plurality of locations or regionsof the second flap are configured to be attached to. The biomechanicalcharacteristics at the plurality of locations or along the plurality ofregions may be defined by using one of the several ways as discussedabove. The biomechanical characteristics of the arbitrary selectablelocations can be dependent on spatial coordinates along the posteriorvaginal wall and specific individual subject attributes. In a similarmanner, the third flap 206A of the first implant 200A may be configuredin accordance with some embodiments. Similarly, implants of variousother shapes such as the implant 1000 with the elongate body member 1002of FIGS. 10 and 11 without limitations may also be configuredaccordingly in a similar manner such that for example, the biomechanicalcharacteristics of a plurality of locations or a plurality of regions onthe elongate body member 1002 may be defined in accordance witharbitrary selectable locations or regions of the bodily portion wherethe medial portion 1008 of the elongate body member 1002 is configuredto be attached to as discussed in conjunction with FIGS. 10 and 11.

FIG. 13A illustrates a perspective view of an implant such as theimplant 100 or 200 or 200A or 200B of FIGS. 1-9, and 12 placed inside apatient's body, in accordance with an embodiment of the invention. FIG.13B illustrates a perspective view of an implant such as the implant1000 of FIGS. 10 and 11 placed inside a patient's body, in accordancewith an embodiment of the invention. The body portions of the patientsuch as vagina 1302, anterior vaginal wall 1304, posterior vaginal wall1306, sacrum 1308, and urethra 1310 are illustrated in FIGS. 13A and13B.

FIG. 14 illustrates a method 1400 for placing an implant such as theimplant 200 in a patient's body. The method 1400 is described below inconjunction with FIGS. 13A and 13B, as an example without limitations.The implant 200 is used as an exemplary embodiment to illustrate anddiscuss the method 1400. However, it must be appreciated that otherimplants such as the implant 100 or 200A or 200B can also be employedwithout limitations.

The method 1400 may include inserting the first flap 202 of the implant200 inside the body of a subject at step 1402. In some embodiments, thefirst flap 202 can be inserted inside the patient's body through alaparoscopic approach. In some embodiments, the method 1400 includescreating an abdominal incision such that the implant 200 can bedelivered inside the body using a laparoscopic approach.

The method 1400 may include attaching the first flap 202 of the implant200 to the anterior vaginal wall 1304 at step 1404. The first flap 202may be configured in accordance with the anterior vaginal 1304 wall of aspecific subject. The method 1400 further includes attaching the secondflap 204 of the implant 200 at the posterior vaginal wall 1306 at step1406. The second flap 204 may be configured in accordance with theposterior vaginal wall 1306.

The method 1400 further includes attaching the third flap 206 of theimplant 200 at the sacrum 1308 or proximate tissues inside the patient'sbody at step 1408.

In some embodiments, the method 1400 can be used for treatment of apelvic floor disorder. For example, the implant 200 may be used forvaginal prolapse treatment to suspend the vagina 1302 to the sacralpromontory or the sacrum 1308 after hysterectomy through theSacrocolpopexy procedure or without hysterectomy or through any otherprocedure. In other embodiments, the method 1400 may be used to treatother disorders. In some embodiments, the method 1400 may includecreating an abdominal incision or multiple abdominal incisions fordelivering the implant 200 inside the body laparoscopically. In anembodiment, the method 1400 may include creating vaginal and/or groinincisions for delivering the implant 200 through other procedures. In anembodiment, the method 1400 may include cutting unneeded portions of theflaps 202, 204, and 206 or sutures after the procedure is complete andremoving the unneeded material. In an embodiment, the method 1400 mayinclude attaching the flaps 202, 204, and 206 to bodily tissues usingsutures, staples, anchors, bonding agents such as glues, mechanicalstaplers, or in any other manner. The method 1400 includes closing theincisions after the procedure is complete.

In some embodiments, the procedure of placing the implant 200 within thebody can be performed after performing hysterectomy and removal ofuterus from the body. In some other embodiments, the implant 200 can beplaced even without removing the uterus and the uterus can remain assuch.

FIG. 15 illustrates a method 1500 for placing an implant such as theimplant 1000 in a patient's body in accordance with an embodiment. Themethod 1500 is described herein in conjunction with FIGS. 13A and 13B.As illustrated, the implant 1000 is positioned underneath urethra forproviding a support to sub-urethral tissues to prevent leakage of urinedue to incontinence in particular stress urinary incontinence. Themethod 1500 may include creating a vaginal incision or an abdominalincision at step 1502. The method 1500 further includes inserting theimplant 1000 inside the patient's body at step 1504. The differentportions of the elongate body member 1002 or the medial portion 1008 maybehave in accordance with the respective different portions of thesub-urethral tissues where the medial portion 1008 is configured to beattached. After inserting the implant 1000 inside the patient's body,the implant 1000 is placed underneath the urethra (or the bladder neckin other embodiments) of the patient at step 1506 such that the medialportion 1008 of the elongate body member 1002 that is exposed to abodily tissue contacts the bodily tissue. In an embodiment, the firstportion 1004 and the second portion 1006 may be covered by sleeves, suchas the sleeves 1102 and 1104 so that only the medial portion 1008 maycontact the bodily tissue directly.

In some embodiments, the position of the implant 1000 may be adjusted.The implant 1000 is adjusted in a manner that the implant 1000 contoursan outer surface of the urethra that is in contact with the implant1000. The physician may further adjust tension of the implant 1000 toreadjust the implant 1000 to provide it an appropriate tension foreffective placement and treatment. The tensioning of the implant 1000may require stretching of the implant 1000. After tensioning the implant1000, the method 1500 may further include removing the sleeves 1102 and1104.

In accordance with some embodiments, the method 1500 further includestrimming a portion of the implant 1000. The trimmed portion can betucked to the bodily tissues under skin ore removed from the body. Inaccordance with various embodiments, incisions such as vaginal incision,groin incisions, abdomen incision, or any other skin incision are closedat step 1508.

In various embodiments, exemplary ways of defining or obtaining desiredbiomechanical characteristics of the flaps such as but not limited to202, 204, and 206 of the various types of implants such as but notlimited 200 discussed in the document are provided elsewhere in thedocument in conjunction with various figures. Some of them are discussedherein without limitations. It must be however appreciated that moreways of defining the biomechanical characteristics or varying thebiomechanical characteristics of the flaps 202, 204, and 206 accordingto requirements can be used without limitations. The biomechanicalcharacteristics of the elongate body member 1002 may also be definedaccordingly using one or a combination of these ways.

In some embodiments, filaments or fibres of the flaps 202, 204, and 206may be treated with adhesives or bending agents. In an embodiment, thefibres or filaments may be welded to adjacent filaments.

In some embodiments, different materials may be used to form differentportions or locations of the flaps or different flaps 202, 204, and 206such that the different materials may provide different characteristicsto the different portions of the implant 200 or to different flaps 202,204, and 206 of the implant 200.

In some embodiments, the different locations or portions of the implantflaps 202, 204, and 206 or different flaps 202, 204, and 206 may includedifferent number of filaments.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may includedifferent weave patterns.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may includedifferent knit patterns.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may include acoating or multiple types of coatings such as for example a siliconecoating so as to vary elasticity or other biomechanical characteristics.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may beannealed or softened or hardened using various mechanical or chemicalprocesses with respect to other portions of the flaps 202, 204, and 206or with respect to other flaps 202, 204, and 206.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may becontacted with heat, radiation, or treated with chemicals or otheragents for providing different characteristics.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may includereinforcing members or different types of reinforcing members.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may includeflat or planar sheets of material. The sheets of material may havedifferent pore quantities or distributions to provide differentcharacteristics at different portions of the flaps 202, 204, and 206 orin different flaps 202, 204, and 206.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may includedifferent types of laminated materials or different types oflaminations.

In some embodiments, the different locations or portions of the flaps202, 204, and 206 or the different flaps 202, 204, and 206 may beweakened to provide different characteristics. For example, in someembodiments, portions of the flaps 202, 204, and 206 or different flaps202, 204, and 206 may be notched, scored, or shaved to introduceweakness or to weaken different portions of the implant 200.

In accordance with some embodiments, the shapes of the first flap 202and the second flap 204 may be different based on anatomical shapes ofthe anterior vaginal wall and the posterior vaginal wall.

In some embodiments, different knit structures of the flaps 202, 204,and 206 or different portions of the same flap 202, 204, or 206 can bedefined by different pore constructs. For example, the different poreconstructs may include different types of pores. In some embodiments,this may be obtained such as by weaving a mesh with different pore sizesand the like. In some embodiments, this may be obtained by extruding asingle pore size mesh and heat setting the pores to set a different poresize.

In some embodiments, one or more of the biomechanical characteristicscan be defined by a material used for fabricating the flaps 202, 204,and 206 or different portions of the same flap 202, 204, or 206. Forexample, a viscoelastic medical grade polymer may be used forviscoelasticity effects. In some embodiments, an anisotropic medicalgrade polymer may be used for obtaining desired anisotropicity in theflaps or different portions of the same flap 202, 204, or 206. In someembodiments, a creep resistant medical grade polymer may be used for adesired creep resistance.

In an example, an imaging device may be used to develop a biomechanicalcharacteristics pattern of bodily tissues such as the sub-urethralfascia or bladder neck or vaginal walls or other tissues. The variousimplants discussed above may be configured to define a continuousgradient of varying biomechanical characteristics along the flaps 202,204, and 206 or elongate body member 1002 or along the medial portion1008 of the elongate body member 1002 in accordance with thebiomechanical characteristics pattern of the bodily tissues such thatthe implant 200 behaves in accordance with the biomechanical behaviourof the bodily tissues. In an example, the pattern or characteristics ofthe implant 200 may vary throughout the elongate body member 1002 or theflaps 202, 204, and 206 in multiple directions in accordance with adesired gradient of varying biomechanical characteristics at differentlocations. The flaps 202, 204, and 206 or the elongate body member 1002may be configured, designed and fabricated using computer assisteddesigning, modelling, and fabrication methods. Exemplary methods andsystems are discussed alter in conjunction with subsequent figures inthe document without limitations.

In accordance with various embodiments, the biomechanicalcharacteristics of the different locations or regions or portions or atarbitrary selectable locations or along a space gradient (indicative ofchange in variations of biomechanical properties or characteristics withevery change in space coordinate) on a vaginal wall, sub-urethraltissues or bladder neck tissues or any other tissues may be determinedusing a variety of imaging, modelling and/or testing proceduresinvolving use of simulation systems, modelling systems, computingsystems, intelligent devices, sensors, programmers, software and thelike that may together be referred to as a biomechanical patternrecognition device 1600 such as shown in FIG. 16. It must be appreciatedthat the biomechanical pattern recognition device 1600 may be used todetermine patterns of various localized biomechanical characteristics oraverage biomechanical characteristics on a portion or region of tissues.In an example, the biomechanical characteristics at a bodily tissue mayvary at every next point or every next location of the bodily tissuewhich can be represented through the biomechanical characteristicpattern that indicates variations of the biomechanical characteristicsat different arbitrary selectable locations. The implant 200 or 1000 orany other implant as discussed above may be configured according to thebiomechanical characteristics pattern such that at every next point orarbitrary selectable location on the implant 200 or 1000, thebiomechanical characteristics may vary depending on the biomechanicalcharacteristics pattern of the bodily tissue. The every next point maybe approximated to as every next pore of a mesh-based implant 200 or1000 in an embodiment so as to vary characteristics, constructs ormaterials or other parameters of the implant 200 or 1000 at every pore.

FIG. 16 shows the biomechanical pattern recognition device 1600 in anembodiment of the present invention that can be used to determinebiomechanical properties of internal tissues of a body. Thebiomechanical pattern recognition device 1600 can be used to measurebiomechanical properties or characteristics inside the vagina of afemale. However, the biomechanical pattern recognition device 1600 maybe used to determine biomechanical properties of any other internaltissues or organs. In an embodiment, the biomechanical patternrecognition device 1600 can be used to determine stress-strainrelationships. In an embodiment, the biomechanical pattern recognitiondevice 1600 can be used to determine viscoelasticity. In an embodiment,the biomechanical pattern recognition device 1600 can be used todetermine various other biomechanical characteristics as discussedearlier. The biomechanical pattern recognition device 1600 can determinebiomechanical characteristics at arbitrary selectable locations andgenerate a characteristic pattern or profile indicative of thebiomechanical characteristics at the arbitrary selectable locations. Thecharacteristic pattern may be generated in the form of a contourdiagram, scatter diagram, heat map, distribution pattern, line diagrams,or in various other formats without limitations. In an example, thebiomechanical pattern recognition device 1600 can generate specificnumeric values indicative of biomechanical properties or variations inthe biomechanical properties at the arbitrary selectable locations. Thebiomechanical pattern recognition device 1600 may include an imagingdevice 1602, an activator 1604, a probe 1606, sensors 1608 coupled tothe probe 1606, a signal processor 1610, a data acquisition unit 1612, adatabase 1614, and a display unit 1616. The probe 1606 can be insertedinside the vaginal opening in an example. The activator 1604 may performan action that initiates an action to cause a change in the tissues suchas vaginal walls at the arbitrary selectable locations. For example, theactivator 1604 can apply a deforming force in order to determinestress-strain relationships or to determine elasticity orhyperelasticity, in an embodiment. In another embodiment, the activator1604 can apply a chemical spray at the arbitrary selectable location soas to detect a response indicative of change in viscoelasticity orviscosity. In some embodiments, the activator 1604 can be of varioustypes or can include a combination thereof so as to determine varioustypes of biomechanical properties. The imaging device 1602 may detectthe changes and responses at the arbitrary selectable locations afterthe activator 1604 performs the action. For example, in an embodiment,the imaging device 1602 may detect dimensional changes, viscoelasticitychanges, and the like. The data acquisition unit 1612 may receive theresponse and signals indicative of the changes obtained by the imagingdevice 1602. The data acquisition unit 1612 may be coupledcommunicatively with the signal processor 1610 or any other processingcircuit so as to correlate the responses with the action and generate anoutput indicative of the biomechanical characteristic pattern orbiomechanical characteristics measurements at the arbitrary selectablelocations. The output may be represented on the display unit 1616 suchas a screen, monitor, or any other device.

The biomechanical pattern recognition device 1600 may include asimulation system 1618. The simulation system 1618 may be configured tosimulate interactions between the tissues and the implant such as 200 orimplant portion. The simulation system 1618 may further be configured togenerate biomechanical data and behaviour of the tissues such as thevaginal walls if a specific implant with specific biomechanicalcharacteristics at the arbitrary selectable locations for a specificindividual is positioned. The simulation system 1618 may allow modifyingparameters of the implant 200 at the different arbitrary selectablelocations based on the generated biomechanical data so as to define theimplant 200 in such a way that the biomechanical behaviour of theimplant 200 at the arbitrary selectable locations is in accordance withthe tissues or regions where the arbitrary selectable locations of theimplant 200 are configured to be placed. The simulation system 1618 maygenerate a realistic simulation environment for various tissues wherethe implant is attached. The simulation system 1618 provides a user witha capability to define implant parameters accordingly and to generatemodelling interactions. The simulation system 1618 may facilitate togenerate the biomechanical characteristics pattern or biomechanicalcharacteristics at the arbitrary selectable locations without actual invivo procedures performed such as with the help of the activator 1604and probe 1606. In such an embodiment, the simulation system 1618 maystore geometric models of bodily tissues or organs and other pertinentdetails in a database. The simulation system 1618 may be provided withspecific patient attributes so as to generate and determine thebiomechanical characteristics of a specific person at the arbitraryselectable locations by correlating different data elements associatedwith tissue characteristics as obtained from the database 1614 andpatient specific attributes as received from a user input.

Therefore, as discussed above, in conjunction with various embodiments,the biomechanical characteristics (or patterns or profiles) at thearbitrary selectable locations may be determined using either in vivoactual tests, ex vivo actual test, or simulation and modellinginteractions with the help of realistic simulation environment. Thebiomechanical pattern recognition device 1600 may include computer aideddesigning and analytics software packages. The biomechanical patternrecognition device 1600 may further include various other components andsub-components such as power supply, mechanical arrangements orcomponents, circuitry, wires, other electronic or electrical componentsand auxiliary components together shown as 1620 to determine thebiomechanical characteristics.

In an embodiment, the biomechanical pattern recognition device 1600 mayinclude a pressure unit (not shown) for applying a defined pressure toan arbitrary selectable location of a bodily tissue. A sensor may detecta deformation caused by application of the defined pressure.

In an example, different biomechanical pattern recognition devices maybe used for determining different types of properties. For example,strength or strength patterns may be determined using a first devicewhile elasticity or elasticity patterns may be determined using anotherdevice. In some embodiments, the same biomechanical pattern recognitiondevice 1600 may be used to determine various characteristics such thatthe biomechanical pattern recognition device 1600 may involve multiplesub-components each configured to determine a specific biomechanicalproperty or characteristic. The biomechanical pattern recognition device1600 may in such a case generate an output in the form of a series ofvalues indicative of measures of biomechanical characteristics atdifferent regions or portions or locations corresponding to eachcharacteristic or a set of patterns with each pattern indicative ofdistribution of a specific biomechanical characteristic.

In an embodiment, the biomechanical pattern recognition device 1600 maydetermine the biomechanical characteristics in vivo. In an embodiment,the biomechanical pattern recognition device 1600 may determine thebiomechanical characteristics from sample tissues such that output andfindings may be used to extrapolate it for generating characteristics orcharacteristic patterns of specific test group. For example, thebiomechanical pattern recognition device 1600 may determinecharacteristics or characteristic patterns at arbitrary selectablelocations or such as along an entire anterior vaginal wall of specificage group tissues such that an output of the biomechanical patternrecognition device 1600 may be indicative of fairly accuraterepresentation of various biomechanical characteristics at differentarbitrary selectable locations or along an entire vaginal wall of evenanother subject with age similarities with the test group. In anotherexample, however, in vivo measurements may be taken to customize implantdesign and fabrication for specific tissues, tissue locations, and forspecific subjects.

In an embodiment, the biomechanical pattern recognition device 1600 maymeasure the biomechanical characteristics by applying a temporarydeforming force at an arbitrary selectable location of tissues such asvaginal wall tissues, or other pelvic tissues. The deforming force maybe applied through vacuum suction or air pressure or rotational torsion,tissue stretching, or striking the location with an object, and thelike. The biomechanical pattern recognition device 1600 may evaluate howthe tissue responds in response to the applied force as well as how itresponds after the deforming force is removed. The biomechanical patternrecognition device 1600 may use sensors to detect the response duringapplication of the force and after the force is removed. By monitoringthe response at the arbitrary selectable location, the biomechanicalpattern recognition device 1600 may generate a characteristic patternindicative of biomechanical characteristics at the arbitrary selectablelocation or region within and around the arbitrary selectable location.The biomechanical pattern recognition device 1600 may include acomputing component 1622 operably and communicatively connected with theprobe 1606 such that the probe 1606 may be inserted into the vagina andrecord the response upon application of the force. The response may thenbe evaluated by the computing component 1622. The computing component1622 may record the deforming force and the response detected by thesensors 1608 that may be coupled to the probe 1606. The probe 1606 mayinclude sensors such as laser-based sensors, temperature-based sensors,mechanical sensors, ultrasonic sensors, pressure sensors,ultrasound-based sensors, and the like without limitations.

The computing component 1622 may be configured to define an implantpattern based on the biomechanical characteristic pattern of the bodilytissue. The implant pattern may identify parameters of the implant atvarious arbitrary selectable locations defined in a way that thebiomechanical characteristics of the implant 202 at the arbitraryselectable locations are in accordance with the biomechanicalcharacteristics of the bodily tissue. The implant parameters may includesuch as pore size, pore shape, material of fabrication, knit pattern andthe like as discussed elsewhere in the document without limitations. Forexample, the computing component 1622 may be configured to developimplant pattern of the first flap 202 and the second flap 204 of theY-shaped implant 202 (or other implants as discussed above inconjunction with various figures) based on a biomechanicalcharacteristic pattern of respective posterior vaginal wall and anteriorvaginal wall, wherein the first flap 202 is adapted to be attached tothe anterior vaginal wall and the second flap is adapted to be attachedto the posterior vaginal wall.

In an embodiment, the biomechanical pattern recognition device 1600 maydetermine the biomechanical characteristics or characteristic patternsusing a dynamic optical coherence elastography technique. Thebiomechanical pattern recognition device 1600 may determine thebiomechanical characteristics based on mechanical surface wavepropagation that may allow determination of the biomechanicalcharacteristics at the arbitrary selectable locations in vivo indifferent orientations and different directions. In some embodiments,the biomechanical characteristics may be determined through opticalimaging techniques such as optical elastography, optical sensing andimaging, optical coherence elastography, multiphoton electrography,magnetomotive microscopy; vaginal tactile imaging, ultrasoundelastography; cross-sectional imaging-based elastography; MRIelastography; MRI, 2-D or 3-D imaging, optical scattering variations,biomedical imaging, diffraction phase microscopy, micro-scale mapping,tensile tests, digital image correlation, statistical analysis,deformation tests, mechanical imaging such as tactile imaging, stressimaging and the like, 2-D or 3-D image reconstruction, or any othertechnique without limitations for determining various types ofbiomechanical properties. In an embodiment, mechanical imaging may beemployed to generate biomechanical characteristic pattern or profilesfor vaginal walls. For example, the biomechanical pattern recognitiondevice 1600 may include a transvaginal probe such as the probe 1606, anelectronic unit, and a computing device. The vaginal probe may includesensors similar to the sensors 1608.

It must be appreciated that the biomechanical pattern recognition device1600 discussed herein can be used in an exemplary embodiment. However,several other types of pattern recognition systems or devices todetermine biomechanical characteristics may be employed withoutlimitations.

In accordance with some embodiments, the biomechanically compatibleimplant discussed throughout the document, number of arbitraryselectable discrete locations on each flap or on an elongate body membermay be at least fifty such that the biomechanical characteristics at thearbitrary selectable at least fifty discrete locations of the flap orthe elongate body member of the implant varies in accordance withvariations in the biomechanical characteristics of the arbitraryselectable at least fifty discrete locations of the anterior vaginalwall or posterior vaginal wall or sub urethral tissues. In accordancewith some embodiments, the biomechanically compatible implant discussedthroughout the document, number of arbitrary selectable discretelocations on each flap or on an elongate body member may be at leastfive such that the biomechanical characteristics at the arbitraryselectable at least five discrete locations of the flap or the elongatebody member of the implant varies in accordance with variations in thebiomechanical characteristics of the arbitrary selectable at least fivediscrete locations of the anterior vaginal wall or posterior vaginalwall or sub urethral tissues. In an example, the at least one of thearbitrary selectable five or fifty discrete locations extends along apartial length of the first flap or the second flap or the elongate bodymember. In an example, the at least one of the arbitrary selectable fiveor fifty discrete locations extends along a partial width of the firstflap or the second flap or the elongate body member. The biomechanicalcharacteristics of the first flap or the second flap or the elongatebody member at the arbitrary selectable discrete locations are definedbased on an input signifying age, pregnancy or childbirth state,intra-abdominal forces interactions, and state of prolapse associatedwith a subject and the like.

FIG. 17 illustrates a 3D (three dimensional) printing ecosystem 1700 (orsystem 1700) for fabrication of an implant such as the implant 200 orother implants discussed in accordance with various embodiments above,in an embodiment of the present invention. The system 1700 may include a3D printer (also referred to as additive manufacturing device) 1702, acomputing system 1704, a materials section 1706, a data section 1708,user input interfaces 1710, output peripheral interfaces 1712, numericalcontrol machines 1714, and other automated systems 1716.

The 3D printer 1702 may be configured to perform one or more additivefabrication or layered manufacturing processes to manufacture acustomized and smart implant such as the implant 200 that mimicsbehaviour of tissues where the implant is configured to be attachedwherein biomechanical characteristics of the implant 200 at arbitraryselectable locations after fabrication and when placed within the bodyare in accordance with biomechanical characteristics at arbitraryselectable locations of the tissues where the respective arbitraryselectable locations of the implant 200 are placed.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute fused deposition modeling (FDM)™ processes. The process ofFDM™ may involve a software process which may process an STL(stereolithography) file or any other file format. The STL file may forexample contain details about the biomechanical characteristic patternof the tissues at the arbitrary selectable locations or implantbiomechanical characteristic pattern based on the biomechanicalcharacteristic pattern of the tissues. An object may be produced byextruding small beads of for example thermoplastic or any other materialto form layers as the material hardens immediately after extrusion froma nozzle. A material filament or wire is unwound from a coil andsupplies material to an extrusion nozzle which can turn the flow on andoff. A worm-drive or any other drive system may be provided to push thefilament into the nozzle at a controlled rate. The nozzle is heated tomelt the material. The nozzle can be moved in both horizontal andvertical directions. The nozzle may follow a tool-path controlled by acomputer-aided manufacturing (CAM) software package, and the object isfabricated from the bottom up, one layer at a time.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute electron beam freeform fabrication processes. The ElectronBeam Freeform Fabrication (EBFFF) process may utilize electron beamwelding technology to create parts. In an aspect of the invention, withthe EBFFF method, metallic preforms can be manufactured fromcomputer-generated 3D drawings or models. The deposition path andprocess parameters may be generated from post-processing of a virtual 3Dmodel and executed by a real-time computer control. The deposition takesplace in a vacuum environment. A wire may be directed toward the moltenpool and melted by a focused EB. Different parts of the object to befabricated are built up layer by layer by moving the EB and wire sourceacross a surface of underlying material referred to as substrate. Thedeposit solidifies immediately after the electron beam has passed.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute direct metal laser sintering process (DMLS). DMLS process mayinvolve a laser as a power source to sinter powdered material such as ametal or any other material at points in space defined by a 3D modelthus binding the material together to create a solid structure. The DMLSprocess may involve use of a 3D CAD model whereby a .stl file is createdand sent to the 3D printer's software. The DMLS-based 3D printer 1702uses a high-powered fiber optic laser. The metal powder is fused into asolid part by melting it locally using the focused laser beam. Objectparts are built up additively layer by layer.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute selective laser melting (SLM) process. The SLM process uses3D CAD data as a digital information source and energy in the form of ahigh-power laser beam to create three-dimensional parts by fusing finepowders together. The process involves slicing of the 3D CAD file datainto layers to create a 2D image of each layer. Thin layers of atomizedfine powder are evenly distributed using a coating mechanism onto asubstrate plate that is fastened to an indexing table that moves in thevertical (Z) axis. This takes place inside a chamber containing atightly controlled atmosphere of inert gas such as argon. Once eachlayer has been distributed, each 2D slice of the geometry is fused byselectively applying the laser energy to the powder surface, bydirecting the focused laser beam using two high frequency scanningmirrors in the X and Y axes. The laser energy permits full melting ofthe particles to form solid metal. The process is repeated layer afterlayer until the part is complete.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute selective heat sintering process. The process may involve athermal printhead to apply heat to layers of powdered thermoplastics orother materials. When a layer is finished, the powder bed of materialsmoves down and an automated roller adds a new layer of material which issintered to form a next cross-section of the object.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute selective laser sintering process. The process of selectivelaser sintering (SLS) involves a laser used to melt a flame-retardantplastic or synthetic material powder, which then solidifies to form theprinted layer.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute plaster-based 3D printing processes.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute laminated object manufacturing process. In this process,layers of adhesive-coated material laminates may be successively gluedtogether and cut to shape with a knife or laser cutter.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute stereo-lithography (SLA) processes. The process may employ avat of liquid ultraviolet curable photopolymer “resin” and anultraviolet laser to build layers one at a time. For each layer, thelaser beam traces a cross-section of the part pattern on the surface ofthe liquid material. Exposure to the ultraviolet laser light cures andsolidifies the pattern traced on the resin and joins it to the layerbelow.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute digital light processing (DLP) methods. Digital LightProcessing uses a projector to project an image of a cross section of anobject into a vat of photopolymer (light reactive plastic). The lightselectively hardens only the area specified in that image. A printedlayer is then repositioned to leave room for unhardened photopolymer tofill newly created space between the print and the projector. Repeatingthis process builds up the object one layer at a time.

In accordance with an embodiment, the 3D printer 1702 may be configuredto execute photopolymerization methods. In this process, drops of aliquid plastic or other synthetic material are exposed to a laser beamof ultraviolet light. During this exposure, light converts the liquidinto a solid.

In accordance with some embodiments, the 3D printer 1702 may involve useof an inkjet type printhead to deliver a liquid or colloidal bindermaterial to layers of a powdered build material. The printing techniquemay involve applying a layer of a powdered build material to a surfacesuch as using a roller. After the build material is applied to thesurface, the printhead delivers the liquid binder to predetermined areasof the layer of material. The binder infiltrates the material and reactswith the powder, causing the layer to solidify in the printed areas by,for example, activating an adhesive in the powder. After the firstcross-sectional portion is formed, the steps are repeated and successivecross-sectional portions are fabricated until the final object isformed.

In an aspect, the methods performed by the 3D printer 1702 may involvedeposition of successive layers of a build material on a rotary buildtable and deposition of a liquid in a predetermined pattern on eachsuccessive layer of the build material to form a three-dimensionalimplant.

The data section 1708 may include various components and sub-componentssuch as a data acquisition system 1718, various data libraries 1720, anddata sources 1722, without limitations.

The data acquisition system 1718 may receive or acquire data signal fromexternal or internal environments including the data sources 1722 andconvert them into digital information for use by the 3D printer 1702 andthe computing system 1704 to process the digital information formanufacturing a three-dimensional implant using the successive layersdeposition techniques.

The data section 1708 may include the data libraries 1720 that maycontain predefined information for use by the 3D printer 1702 and thecomputing system 1704 to create custom designed and custom definedimplant that exhibit biomechanical characteristics pattern in accordancewith biomechanical characteristics pattern of bodily tissues. The datalibraries 1720 may include implant pattern templates 1724 that maycontain different predefined templates of patterns for a biomechanicallycompatible implant for use at various bodily tissues such as an anteriorvaginal wall, a posterior vaginal wall, sub-urethral facia, bladder necketc. The predefined implant pattern templates 1724 may be directly usedby the 3D printer 1702 to fabricate the implant such as 200, in anembodiment. In another embodiment, the implant pattern templates may beused and modified slightly or substantially in accordance with thedigital information acquired through the data sources 1722 to customizethe implant 200. The data libraries 1720 may further include designlibraries 1726 that may contain three dimensional or two dimensional orCAD designs of various types of implants for use in fabrication. Forexample, the design library 1726 may store a CAD design or model of aY-shaped implant such as 200 or a linear strip-based implant such as1000 with an elongate body member 1002, and the like such that thedesigns and models of the implants may be refined with the use of theimplant pattern templates 1724 for customization of the implant 200 of aspecific design with a specific pattern. The data library 1720 mayfurther store implant non-mesh pattern parameters 1728 that may be usedto define or vary biomechanical characteristics of a non-mesh-basedimplant. For example, the non-mesh pattern parameters 1728 may includesuch as fabrication method, material deposition or layering technique,type of material for fabrication, thickness of deposition material,width, shape, and others such as those discussed elsewhere in thedocument without limitations. The data library 1720 may further storeimplant mesh-pattern parameters 1730 that may be used to define or varybiomechanical characteristics of a mesh-based implant. For example,different implant mesh pattern parameters 1730 may include such as poreconstruct, pore shape, pore size, fibre orientation, and others such asthose discussed elsewhere in the document without limitations. The datalibraries 1720 may store tissue patterns and models 1732 that maycontain digitally maintained information of patterns and models ofvarious bodily tissues and associated biomechanical characteristics atdifferent arbitrary selectable locations or regions. For example, tissuepatterns and models 1732 of an anterior vaginal wall may be provided inthe data libraries 1720 to define an interactive and user retrievableinformation base wherein a user of the 3D printer 1702 or the computingsystem 1704 or various other systems in the ecosystem 1700 mayselectably identify and retrieve biomechanical characteristics atarbitrary selectable locations or regions of a bodily tissue. Thebiomechanical characteristics may be provided to the other components orsub-components for further processing before defining a customizedimplant and manufacturing thereof through the 3D printer 1702. In anexample, the tissues patterns, designs and models 1732 may not representbiomechanical characteristics of a particular individual with completeaccuracy but may provide a generic information about how a particulartissue or an arbitrary selectable region or location at the tissue maybehave so that this information may be used by the computing system 1704to further process it for defining a desired design of the implant 200for an individual or for a particular location or region of the tissue.The data libraries 1720 may further store details aboutparameters-biomechanical characteristics relationships 1734. Theparameters-biomechanical characteristics relationships 1734 mayassociate relationships between different biomechanical characteristicsand various implant parameters such as implant mesh-pattern parameters1730 and implant non-mesh pattern parameters 1728. For example, therelationships may define how for example elasticity may vary with achange in a specific parameter such as a pore construct etc.

The data sources 1722 may include different information sources or datasources such that the data acquisition system 1718 may operativelyand/or communicatively be connected with the data sources 1722 toretrieve the digital information for defining manufacturing inputsprovided by the user to the 3D printer 1702 through user inputinterfaces 1710. The information obtained from the data sources 1722 maybe directly provided to the 3D printer 1702, in an embodiment. Inanother embodiment, the information may be provided to other systemssuch as the computing system 1704 etc for further processing beforebeing given to the 3D printer 1702. The data sources 1722 may forexample include biomechanical pattern recognition device inputs 1736that may include information or data provided by the biomechanicalpattern recognition device 1600 of FIG. 16 or any other recognitiondevice. The biomechanical pattern recognition device inputs 1736 may forexample include biomechanical pattern of the tissues and/orbiomechanical pattern of the implant at the arbitrary selectablelocations or regions. The data sources 1722 may further include userinput 1746 that may be entered by the user during operation of the 3Dprinter 1702 or during accessing different components of the ecosystem1700 or during manipulating data flow across different components andsub-components. The data sources 1722 may include simulation output 1748that may include information generated by a modelling and simulationsystem such as a modelling and simulation system 1738 described later.The data sources 1722 may include implant feedback information 1740which may be obtained from physicians or doctors or electronic medicalrecords (EMR) after the implant 200 is already delivered and used in asubject's body. The subject may experience the implant 200 andaccordingly information based on real experience of the implant 200 bythe subject or based on actual behaviour of the implant 200 withinbodily tissues may be maintained by the doctor manually or in an EMR.This information may be termed as implant feedback or subject feedbackherein. The data sources 1722 may further include subject attributes1742 that may define specific characteristics or data elementsassociated with an individual subject which may be used to customize theimplant 200 for the specific individual. The subject attributes 1742 mayfor example include, age, unique individual tissue characteristics,pregnancy state, gender, and other such attributes as mentionedelsewhere in the document.

The user input interfaces 1710 may include input devices such as akeyboard, mouse, touch screen device, interactive or non-interactiveuser interfaces, graphical input devices, voice recognition systems, andother input devices.

The computing system 1704 may include a biomechanical patternrecognition device 1750, an image processing system 1752, the modellingand simulation system 1738, a processor 1754, a memory section 1756, acustomization engine 1758, control software 1760 to control fabricationparameters, a materials management unit 1762, a print server 1764, andvarious other systems or components or sub-components.

The biomechanical pattern recognition device 1750 may be similar to thebiomechanical pattern recognition device 1600. In an embodiment, thepattern recognition device 1750 may be integrated within the ecosystem1700 such that a separate biomechanical pattern recognition device 1750may not be needed. The image processing device 1752 may performprocessing of scanned or other images or patterns of bodily tissues orimplant as obtained or created by the biomechanical pattern recognitiondevice 1750 or other components or systems. The image processing device1752 may include or be coupled to a scanner or a camera in anembodiment. The materials management unit 1762 may control flow ofmaterials from the materials section in accordance with requirements ofdifferent materials in different amounts at different times at differentarbitrary selectable locations or regions of the implant 200 duringdeposition or 3D printing. The different materials or a combination ofdifferent materials may contribute to varying biomechanicalcharacteristics of the implant 200 at the different arbitrary selectablelocations or regions. The computing system 1704 may include thecustomization engine 1758 for generating a 3D printable and computerexecutable file using information generated from various components andsub-components of the ecosystem 1700 and information retrieved from thedata sources 1722 so that an output generated by the customizationengine 1758 when input into the 3D printer 1702 allows the 3D printer1702 to fabricate the implant 200 (or 1000 or other implants in variousembodiments) with desired patterns at the arbitrary selectable locationsin accordance with customized inputs for the customized implant 200. Thecomputing system 1704 may include control software 1760 for controllingmaterials deposition and other fabrication control parameters duringprinting processes such that the controlled fabrication or printing bythe 3D printer 1702 based on instructions by the control software 1760fabricates the desired biomechanically compatible implant 200. Thecomputing system 1704 may include the print server 1764 that may becoupled communicatively through a network to various other systems,components and sub-components of the ecosystem 1700 and other remotelylocated devices or server or other 3D printing ecosystems similar to the3D printing ecosystem 1700 or a plurality of other 3D printers includingprinters similar to the 3D printer 1702 without limitations. The printserver 1764 may provide a control of the various systems within oroutside the ecosystem 1700 over the network and facilitate networkingoperations among the various devices, systems, components,sub-components of the ecosystem 1700 themselves and/or across otherdevices, systems, components, sub-components of other ecosystems. Theprint server 1764 may facilitate an automated fabrication operation ofthe 3D printer 1702 or several networked 3D printers with minimal or nosupervision.

The computing system 1704 may include the processing circuit or theprocessor 1754 for performing various routine processing and computingactivities of the computing system 1704. The processor 1754 may beconnected with the memory circuit or memory section 1756 for storingcomputer executable programmed instructions to execute the processingfunctions or activities by the processor 1754 or other components orsub-components of the computing system 1704.

The computing system 1704 may further include the modelling andsimulation system 1738. The modelling and simulation system 1738 mayinclude a computer aided designing (CAD) section 1766, statistical andanalytical tools 1768, artificial intelligence and machine learningtools 1770, a simulation engine 1772 and other components for developingsimulation scenarios and generating predictive models based on asimulation output. The CAD section 1766 may include CAD designing toolsfor developing models of bodily tissues, implant patterns, biomechanicalcharacteristics patterns that may be supplied to the data libraries 1720or other components of the data section 1708 or to the variouscomponents of the computing system 1704 for further processing todevelop the computer executable and 3D printable file defining inputparameters for fabrication of the 3D printable implant. The file can bea .stl file in an embodiment. In another embodiment, the file can becreated in other format. The designs and models developed by the CADsection 1766 may be generated based on a predictive behaviour bycreating a real like simulated environment by the simulation engine1722. The simulation engine 1722 may utilize several statistical andanalytical tools, and artificial intelligence and machine learning toolsto develop a simulated environment so that behaviour of the implantmodels or designs may be examined prior to fabrication in accordancewith behaviour of the bodily tissues within the body where the implant200 may be configured to be attached.

The ecosystem 1700 may include the materials section 1706 that maycontain a plurality of chambers containing different materials for usein fabrication of the biomechanically compatible implant 200 such thatthe materials from the different chambers flow in accordance withinstructions from the computing system 1704 or the materials managementunit 1762 so as to use a combination of materials based on requirementsof the materials at the different arbitrary selectable locations orregions of the implant 200 to be fabricated by the 3D printer 1702. Thematerials section 1706 may include a plurality of sensors operatively orcommunicatively connected with the materials chambers to control andmonitor flow of the materials to the 3D printer 1702 as instructed bythe computing system 1704.

The 3D printer 1702 may be communicatively and operatively connectedwith the numerical control machines (NCM) 1714 and other automatedsystems such as robots 1716 etc for automatically facilitating otherfabrication processes in association with 3D printing or layereddeposition.

The printed implant 200 may be received at the output peripheralinterfaces 1712 that may include mechanical components for receiving theprinted implant 200 or computer interfaces for executing post-printingtasks such as interactive interfaces for reviewing the implant behaviouror examining the printed implant various characteristics and the like.

In accordance with various embodiments of the present invention, 3D(three-dimensional) printing or additive manufacturing or fabricationmay be referred to as a manufacturing technique or technology formanufacturing of three-dimensional objects using additive processes suchas layered deposition in which successive layers of one or more types ofmaterials are laid down under control of programmed instructions. The 3Dprinting fabrication technique as discussed above may be employed tomanufacture implants or other objects of almost any shape, size,characteristic, geometry, etc. The above embodiment is discussed inconjunction with the implant 200. However, it must be appreciated thatother implants such as 100 or 1000 may also be designed and/orfabricated in a similar manner.

In accordance with various embodiments discussed above, the implant 200may be used for or adapted with slight modifications to be used forurinary incontinence, fecal incontinence, breast implant, hernia,abdominal repair, various types of prolapse, breast uplift, or variousother types of treatment options or reconstructive or plastic orartificial tissue growth surgeries, and the like without limitations.

In accordance with various embodiments, the implant discussed in thisdocument provides several advantages. The biomechanically compatible orbiomechanically suitable implant is designed and fabricated inaccordance with the biomechanical properties or characteristics ofbodily tissues and therefore the implant mimics the behaviour of thebodily tissues. This reduces the chances of complex issues that mayarise due to rejections of a foreign material such as the implant by abody. For example, since the biomechanical behaviour of the implant issimilar to the biomechanical behaviour of the bodily tissue, there is areduced chance of issues such as contraction, extrusion, erosion of theimplant. Further, the chances of infection can be reduced. Further, acustomized implant manufactured through an additive process such as buythe 3-D printer (or additive manufacturing device) or using any otherdevice through any other process can be designed and provided based onrequirements of each specific individual subject or patient.

While the invention has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present invention isnot to be limited by the foregoing examples, but is to be understood inthe broadest sense allowable by law.

What is claimed is:
 1. A biomechanically compatible implant forproviding support to sub-urethral or bladder neck tissues to preventleakage of urine due to incontinence, the biomechanically compatibleimplant comprising: a linear strip of mesh with a proximal portion, amedial portion and a distal portion, wherein the medial portion isconfigured to be attached to sub-urethral or bladder neck tissues forproviding a supporting force to the sub-urethral or bladder necktissues, wherein arbitrary selectable discrete locations of the medialportion of the linear strip of mesh that contacts the sub-urethral orbladder neck tissues are defined to exhibit biomechanicalcharacteristics in accordance with biomechanical characteristics atarbitrary selectable discrete locations of the sub-urethral or bladderneck tissues where the respective arbitrary selectable discretelocations of the medial portion are configured to be attached such thatthe biomechanical characteristics of the medial portion of the linearstrip of mesh that contacts the sub-urethral or bladder neck tissues aredifferent at arbitrary selectable discrete locations of the medialportion of the linear strip of mesh; a first sleeve removably coupled tothe proximal portion and configured be removed by pulling away a firstelongate member that removably couples the first sleeve with theproximal portion; a first dilator configured to be attached to an end ofthe proximal portion of the linear strip of mesh.
 2. The biomechanicallycompatible implant of claim 1, wherein number of arbitrary selectablediscrete locations of the medial portion is at least fifty such that thebiomechanical characteristics at the arbitrary selectable at least fiftydiscrete locations of the medial portion of the implant varies inaccordance with variations in the biomechanical characteristics of thearbitrary selectable at least fifty discrete locations of thesub-urethral or bladder neck tissues.
 3. The biomechanically compatibleimplant of claim 1, wherein the biomechanical characteristics at thearbitrary selectable discrete locations of the medial portion of thelinear strip of mesh are defined based on a combination of parameterscomprises pore shape, pore construct, fabricating material, fabricationprocess, knit orientation, knit pattern, weave pattern, number ofstrands, number of pores per unit length, and number of pores per unitwidth.
 4. A device to generate a biomechanically compatible implantpattern for an implant that behaves in accordance with biomechanicalcharacteristics of a bodily tissue, the device comprising: a pressureunit for applying a defined pressure to a location on the bodily tissue;a sensor for detecting a deformation caused by application of thedefined pressure; a data analyzer to correlate values of the deformationand the defined pressure so as to determine a biomechanicalcharacteristic pattern of the bodily tissue in response to the pressure,and a control unit to define an implant pattern based on thebiomechanical characteristic pattern of the bodily tissue such that atan arbitrarily large plurality of discrete spatial coordinates,biomechanical characteristics of the implant conform with biomechanicalcharacteristics at respective spatial locations of the bodily tissuewhere the respective spatial coordinates of the implant are configuredto be positioned.
 5. The biomechanically compatible implant of claim 4,wherein number of arbitrarily large plurality of discrete spatialcoordinates of the implant is at least fifty.
 6. A system for developinga mesh-based implant, the method comprising: a modeling system forgenerating design models corresponding to the implant using a set ofmachine learning tools, modeling tools, and data sources acquired from aplurality of sources, wherein one of the data sources include subject'sbiomechanical characteristics at arbitrarily large number of locationsof a bodily tissue where the implant is configured to be attached,wherein the design models are contained in a software file; an additivemanufacturing device configured to develop the implant by depositinglayered structures based on the design models contained in the softwarefile readable and executable by the additive manufacturing device, sothat, at arbitrarily large number of locations of a so fabricatedimplant, biomechanical characteristics conform with the biomechanicalcharacteristics of the arbitrarily large number of locations of thebodily tissue where the arbitrarily large number of locations of theprinted implant are configured to be attached.
 7. The system of claim 6,wherein the mesh-based implant is a Y-shaped implant configured torepair prolapse vaginal walls through a sacrocolpopexy procedure.
 8. Thesystem of claim 6, wherein the mesh-based implant includes an elongatebody member configured to support urethral tissues for repairing urinaryincontinence.